Luventa XL 16mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Galantamine hydrobromide

Available from:

Fontus Health Ltd

ATC code:

N06DA04

INN (International Name):

Galantamine hydrobromide

Dosage:

16mg

Pharmaceutical form:

Modified-release capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04110000; GTIN: 5060421930152

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
LUVENTA XL 8 MG PROLONGED-RELEASE CAPSULES, HARD
LUVENTA XL 16 MG PROLONGED-RELEASE CAPSULES, HARD
LUVENTA XL 24 MG PROLONGED-RELEASE CAPSULES, HARD
Galantamine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Luventa XL is and what it is used for
2. What you need to know before you take Luventa XL
3. How to take Luventa XL
4. Possible side effects
5. How to store Luventa XL
6. Contents of the pack and other information
1.
WHAT LUVENTA XL IS AND WHAT IT IS USED FOR
Luventa XL is an antidementia medicine used to treat the symptoms of
mild to moderately severe dementia
of the Alzheimer type, a disease that alters brain function.
The symptoms of Alzheimer’s disease include increasing memory loss,
confusion and behavioral changes.
As a result, it becomes more and more difficult to carry out normal
daily activities.
These symptoms are believed to be due to a lack of acetylcholine, a
substance responsible for sending
messages between brain cells. Luventa XL increases the amount of
acetylcholine in the brain and so could
improve the symptoms of the disease.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LUVENTA XL
DO NOT TAKE LUVENTA XL
• If you are allergic to galantamine or any of the other ingredients
of this medicine (listed in section 6).
• If you have severe liver and/or severe kidney disease
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Luventa XL.
Luventa XL should be used in Alzheimer’s disease and not other forms

Summary of Product characteristics

OBJECT 1
LUVENTA XL 16MG PROLONGED RELEASE CAPSULES,
HARD
Summary of Product Characteristics Updated 27-Jul-2016 | Fontus Health
Ltd
1. Name of the medicinal product
Luventa XL 16 mg prolonged-release capsules, hard
2. Qualitative and quantitative composition
Each 16 mg prolonged-release capsule contains 16 mg galantamine (as
hydrobromide).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Prolonged release capsule, hard
Opaque, pale pink size 2 hard gelatine capsules containing two round
biconvex prolonged-release tablets
of 8 mg
4. Clinical particulars
4.1 Therapeutic indications
Luventa XL is indicated for the symptomatic treatment of mild to
moderately severe dementia of the
Alzheimer type.
4.2 Posology and method of administration
Before start of treatment
The diagnosis of probable Alzheimer type of dementia should be
adequately confirmed according to
current clinical guidelines (see section 4.4).
Posology
Starting dose
The recommended starting dose is 8 mg/day for 4 weeks.
Maintenance dose
• The tolerance and dosing of galantamine should be reassessed on a
regular basis, preferably within
three months after start of treatment. Thereafter, the clinical
benefit of galantamine and the patient's
tolerance of treatment should be reassessed on a regular basis
according to current clinical guidelines.
Maintenance treatment can be continued for as long as therapeutic
benefit is favourable and the patient
tolerates treatment with galantamine. Discontinuation of galantamine
should be considered when
evidence of a therapeutic effect is no longer present or if the
patient does not tolerate treatment.
• The initial maintenance dose is 16 mg/day and patients should be
maintained on 16 mg/day for at least
4 weeks.
• An increase to the maintenance dose of 24 mg/day should be
considered on an individual basis after
appropriate assessment including evaluation of clinical benefit and
tolerability.
• In individual patients not showing an increased response or not
tolerating 24 mg/day, a dose reductio